510(k) Report

FDA applicant

Acme Filter Mask, Inc.

New Taipei City, TW1 decision2013–20130 recalls

FDA records 1 decision for Acme Filter Mask, Inc. (New Taipei City, TW) in 2013: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Acme Filter Mask, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Acme Filter Mask, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acme Filter Mask, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FXXMask, Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123115Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc. · 20132cite it

What has FDA decided for it lately?

  • K123115Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc. · 2013

The one decision as Acme Filter Mask, Inc. →

Other applicant names beginning “Acme”

FDA records each applicant name separately; these may or may not be the same firm.

Acme United Corp. 27Acme Medical Scale Co. 10Acme-Monaco Corp. 5Acme Spine, LLC 2Acme Medical, Inc. 1Acme Automatic Disposable 1Acme Portable Machines, Inc. 1